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Help Wanted: FDA Recruiting New CBER Director Ahead Of Gene, Cell Therapy Wave

This article was originally published in RPM Report

Executive Summary

CBER Director Midthun is stepping down at the end of the year, just as the center is moving into an era of more hands-on work in reviewing new therapeutics.

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US HHS is proposing a public-private partnership to assign ratings to manufacturers based on quality/resilience of supply, tied to a purchasing incentive program for providers. The non-agency approach may be key to overcoming industry and political objections.

Drug Shortage Could Be Addressed By ‘Resilience Rating’ From Private Entity Under HHS Plan

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